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  5. NDC Package Code: 68462-504-81 Hailey 1.5/30

NDC Package 68462-504-81 Hailey 1.5/30

Norethindrone Acetate And Ethinyl Estradiol Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
68462-504-81
Package Description:
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (68462-504-79) / 21 TABLET in 1 BLISTER PACK
Product Code:
68462-504
Proprietary Name:
Hailey 1.5/30
Non-Proprietary Name:
Norethindrone Acetate And Ethinyl Estradiol
Substance Name:
Ethinyl Estradiol; Norethindrone Acetate
Usage Information:
Hailey 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE 1LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAROF CONTINUOUS USE OF A METHOD% of Women Experiencing an Unintended Pregnancy in the First Year of Continuous UseMethodLowestExpectedThe authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.TypicalThis term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.(No contraception)(85)(85)Oral contraceptives Combined progestin only0.10.53N/AN/A-Data not available.N/ADiaphragm with spermicidal cream or jelly620Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film)626Vaginal Sponge nulliparous parous9202040Implant0.050.05Injection: depot medroxyprogesterone acetate0.30.3IUD progesterone T copper T 380A LNg 201.50.60.120.80.1Condom without spermicides female male 532114Cervical Cap with spermicidal cream or jelly nulliparous parous9262040Periodic abstinence (all methods)1 to 925Withdrawal419Female sterilization0.50.5Male sterilization0.10.15Adapted from RA Hatcher et al, Reference 7.
11-Digit NDC Billing Format:
68462050481
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1359022 - norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral Tablet
  • RxCUI: 1359022 - ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet
  • RxCUI: 1359022 - ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral Tablet
  • RxCUI: 1359028 - {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) } Pack
  • RxCUI: 1359028 - Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet 21 Day Pack
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Glenmark Pharmaceuticals Inc., Usa
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ETHINYL ESTRADIOL .03 mg/1
  • NORETHINDRONE ACETATE 1.5 mg/1
    • Pharmacologic Class(es):
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
  • Progesterone Congeners - [CS]
  • Progestin - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA209297
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-05-2018
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68462-504-81?

    The NDC Packaged Code 68462-504-81 is assigned to a package of 3 pouch in 1 carton / 1 blister pack in 1 pouch (68462-504-79) / 21 tablet in 1 blister pack of Hailey 1.5/30, a human prescription drug labeled by Glenmark Pharmaceuticals Inc., Usa. The product's dosage form is tablet and is administered via oral form.

    Is NDC 68462-504 included in the NDC Directory?

    Yes, Hailey 1.5/30 with product code 68462-504 is active and included in the NDC Directory. The product was first marketed by Glenmark Pharmaceuticals Inc., Usa on June 05, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 68462-504-81?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 3.

    What is the 11-digit format for NDC 68462-504-81?

    The 11-digit format is 68462050481. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-268462-504-815-4-268462-0504-81